HEMO-INTEGRA: Integrated Intraoperative Hemodynamic Monitoring During Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Study

HEMO-INTEGRA: Feasibility and Description of an Integrated Intraoperative Hemodynamic Monitoring System for Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Observational Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07683299

Acronym

HEMO-INTEGRA

Enrollment

Registered

2026-07-06

Start date

2026-05-27

Completion date

2027-03-01

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass, Hemodynamic Monitoring, Ventricular-Arterial Coupling

Keywords

HEMO-INTEGRA, VExUS, Oxygen Delivery, NIRS, Deep Hypothermia, Transesophageal Echocardiography, Clinical Decision Support

Brief summary

HEMO-INTEGRA is a software system that integrates four domains of intraoperative hemodynamic monitoring in a single dashboard during cardiac surgery with cardiopulmonary bypass (CPB): (1) ventricular-arterial coupling (VAC) analysis using the Balan 2026 method; (2) tissue perfusion and oxygen delivery (EPOC module with Q10 temperature correction); (3) neuromonitoring (NIRS/BIS); and (4) systemic venous congestion assessment via VExUS-TEE (Waldron 2024 method). This pilot observational study evaluates the feasibility and completeness of data capture using HEMO-INTEGRA across five perioperative time points (T0: pre-CPB; T1: early CPB; T2: mid-CPB; T3: rewarming; T4: post-CPB) in adult patients undergoing elective cardiac surgery at Clinica Medellin Sede Occidente, Medellin, Colombia. The system operates in parallel with standard monitoring and does not modify clinical management. No additional procedures are performed on participants beyond standard of care.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* \- Adult patients 18 years or older scheduled for elective cardiac surgery with cardiopulmonary bypass * Standard intraoperative TEE and arterial line monitoring in place * Written informed consent obtained

Exclusion criteria

* \- Emergency surgery * Off-pump cardiac surgery (OPCAB) * Inability to obtain adequate TEE window * Refusal to participate

Design outcomes

Primary

Measure	Time frame	Description
Data Capture Completeness	Intraoperative (0 to 6 hours)	Proportion of cases with complete data capture across all five intraoperative time points (T0 to T4) for all four HEMO-INTEGRA monitoring modules: ventricular-arterial coupling, tissue perfusion, neuromonitoring, and venous congestion assessment.

Countries

Colombia

Contacts

CONTACTHernan D Castro-Arias, MD MSc

hernan_castro@icloud.com+573128633884

PRINCIPAL_INVESTIGATORHernan D Castro-Arias, MD MSc

Clinica Medellin Sede Occidente, Grupo Quiron Salud

Outcome results